The present invention relates to containers having openings and closures for the openings. Specifically, the present invention relates to sterile solution containers that include ports and closures for sealing the port.
There are many applications in which solutions and other liquids are stored in containers that are accessed through ports or the like. Specifically, in the pharmaceutical industry, such containers are utilized to store dextrose, saline, and the like that are supplied to hospitals for infusion into a patient. Typically, the sterile liquid within the container is accessed through ports or the like. Because the fluid within the containers is to be infused intravenously into a patient, it is necessary that the fluid and the container are maintained as a sterile environment. Moreover, to the extent possible, it is necessary for the port through which the container is accessed to be sterile.
Accordingly, it is desirable to seal the port with a closure or other type of protective covering. Of course, because the container is to be accessed through the port, it is necessary that this closure or protective covering be removable. It is also desirable for the closure to be tamper evident so that the user can visually determine if the sterile environment of the port has been violated.
One prior art method of sealing ports is to bond a closure directly to the port. The bond between the closure and the port is constructed so that the closure fractures from the port upon the application of a sufficient force. Difficulty is experienced with these types of closures in that excessive force is sometimes required to fracture or remove the closure. It is also known to provide a closure wherein a frangible section is provided around the closure's base; the frangible section being defined by a series of slots or cuts in the closure. The disadvantage with such a structure is that a sterile environment is not maintained within the closure.
It is also known to provide a frangible section on the closure adjacent to the seal between the closure and the port. However, the frangible sections of these closures commonly require flexural shear force to fracture and the required force is frequently too great for many applications.
Another type of closure for ports is to utilize a polyvinyl chloride sleeve that covers the port and is removed by being slipped back away from the port. Aluminum foil is also utilized and is removed by being pulled off the port. Both of these closures suffer the disadvantage in that they limit the penetration of the steam that is utilized to sterilize the port. This in turn increases the length of time needed to sterilize the container to achieve the desired kill effect.
Accordingly, there is need for an improved closure and port assembly that overcomes the problems and disadvantages of the prior art.